title: Effects of carbohydrate counting on glucose control and quality of life over 24 weeks in adult patients with type 1 diabetes on continuous subcutaneous insulin infusion: a randomized, prospective clinical trial (GIOCAR).
abstract: OBJECTIVE
  Few studies have assessed the efficacy of carbohydrate counting in type 1 diabetes, and none have validated its efficacy in patients who are treated with continuous subcutaneous insulin infusion (CSII). The aim of our study was to test the effect of carbohydrate counting on glycemic control and quality of life in adult patients with type 1 diabetes who are receiving CSII.
  
  
  METHODS
  Sixty-one adult patients with type 1 diabetes treated with CSII were randomly assigned to either learning carbohydrate counting (intervention) or estimating pre-meal insulin dose in the usual empirical way (control). At baseline and 12 and 24 weeks, we measured HbA(1c), fasting plasma glucose, BMI, waist circumference, recorded daily insulin dose, and capillary glucose data, and administered the Diabetes-Specific Quality-of-Life Scale (DSQOLS) questionnaire.
  
  
  RESULTS
  Intention-to-treat analysis showed improvement of the DSQOLS score related to diet restrictions (week 24 - baseline difference, P = 0.008) and reduction of BMI (P = 0.003) and waist circumference (P = 0.002) in the intervention group compared with control subjects. No changes in HbA(1c), fasting plasma glucose, daily insulin dose, and hypoglycemic episodes (<2.8 mmol/L) were observed. Per-protocol analysis, including only patients who continuously used carbohydrate counting and CSII during the study, confirmed improvement of the DSQOLS score and reduction of BMI and waist circumference, and showed a significant reduction of HbA(1c) (-0.35% vs. control subjects, P = 0.05).
  
  
  CONCLUSIONS
  Among adult patients with type 1 diabetes treated with CSII, carbohydrate counting is safe and improves quality of life, reduces BMI and waist circumference, and, in per-protocol analysis, reduces HbA(1c).
authors.affiliation: an Raffaele Vita-Salute University, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Laurenzi
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Bolla
authors.forename: Gabriella
authors.initials: G
authors.lastname: Panigoni
authors.forename: Valentina
authors.initials: V
authors.lastname: Doria
authors.forename: Annachiara
authors.initials: A
authors.lastname: Uccellatore
authors.forename: Elena
authors.initials: E
authors.lastname: Peretti
authors.forename: Alessandro
authors.initials: A
authors.lastname: Saibene
authors.forename: Gabriella
authors.initials: G
authors.lastname: Galimberti
authors.forename: Emanuele
authors.initials: E
authors.lastname: Bosi
authors.forename: Marina
authors.initials: M
authors.lastname: Scavini
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D055104:Infusions, Subcutaneous / Q000379:methods*; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin